Bill Athenson, Third Pole Therapeutics - Antimicrobial Therapies | LSI USA '24

Bill Athenson  0:00  
I'm going to start off with a question, which you can probably answer if you paid attention there you go. If you paid attention to that first slide, named the inhalable gas molecule whose discovery won the Nobel Prize, and is attributed for saving hundreds of 1000s of blue babies and adults with pulmonary hypertension. The first hint is that the therapy invented was invented by third pulse founder Mass General anesthesia chief Dr. Warren's APL giant in the a giant and advancing the field of human oxygenation. Hint number two, it's the only inhalable vasodilator, that reduces pulmonary hypertension without causing a systemic drop in blood pressure. Okay, so there's about 15 people who are disqualified for the answer that question the other 200 of you can, we'll be on the honor system, a show of hands, how many of you think it's nitric oxide? So, nitric oxide was discovered and was made available by the FDA in 1999. It's the physician drug of Choice for treating blue babies. It lowers pulmonary arterial pressure increases oxygenation, reduces inflammation, it's safe. It's fast acting with no systemic side effects. So why is it only being utilized 15% of its potential. And why does it open up a huge market expansion opportunity of over 6 million $600 million over the existing $600 million base. Here's the reason. Nitric oxide is delivered in large, bulky nitric oxide cylinders that are solely dependent on a supply chain coming from private sources. Its high touch logistics require tanks to be returned to the manufacturer and then replenished the users have to keep inventory. They have to stock it, they have to reconcile its usage and get back to the manufacturer to pay them. Users have to be trained. Training is exorbitant. It adds huge costs because most RT departments have over 100 Artis that have to be trained. It's clearly not designed for portability, which is a huge need in the hospital. It's too large and complex for step down units. And as you can see, the form factor is not applicable for transport, which is another huge demand of the hospital. The good thing about tanks makes for good medical drama on TV, if any of you've seen Grey's Anatomy or the good doctor, or even Chicago MD you'll you'll probably notice an episode where a nurse is running down the hallway because their last tank of nitric oxide has run out and they needed in the NICU for a baby and they needed in the ICU for an adult who just had cardiothoracic surgery. We're not going to have that problem. Third poll is developed a way to create nitric oxide in a medical device using electricity and roomier we electrify air, which creates nitric oxide by combining nitrogen and oxygen and filtering out any impurities to deliver pure nitric oxide into a nasal cannula or into a ventilator stream. What that means is you've got unlimited supply of nitric oxide that meets the standards of FDA instantly on demand without any special preparation that's necessary, and it's completely portable for both hospital and home use. So what this creates, is a miniature system treatment that that goes across multiple settings. It allows physicians to use their desired drug of Choice as opposed to vasodilators, nebulized vasodilators that have significant issues relating to aerosolization as well as affecting ventilator systems and clogging those systems up, and also for its greater use in the hospital. Currently, nitric oxide is being used to treat pulmonary embolisms, but in very short supply because of its cost CFOs have regulated the use of nitric oxide only for emergency cases, which still amounts to about $600 million in the market. So our same system can deliver a high dose of nitric oxide also as an anti microbial and there's some very exciting work being done at Mass General, the DoD as well as the Gates Foundation, which we're collaborating with. So the market is huge. We have a tremendous opportunity just in the hospital market to take Make over the $600 million existing revenues with our portable system. That opportunity will expand beyond the 600 million when we expand into more than the 800 hospitals that currently use nitric oxide, as well expand and replace inferior vasodilators, which is currently being used because of cost issues. In addition to that, by bringing nitric oxide into the home, we're creating an entirely new market opportunity for a first indication alone for pulmonary hypertensive interstitial lung disease patients. That's an over a billion dollar market opportunity. There's only one drug approved for that market. It's made by United Therapeutics, it's an nebulised vaso dilator, called high vezo. It's only been in the market a year and a half and it's already approaching a billion dollars in sales. So we have a great analog for us to follow both from a sales targeting standpoint, as well as a reimbursement standpoint. Our pipeline is very, very rich, we have the opportunity not only to launch our products in 2025 to take over the hospital market. But we also have an opportunity to leverage off of the work that we're doing with the Gates Foundation with Mass General and the US government relating to using high concentrations of nitric our home our hospital device has the capability to deliver very high concentrations of nitric oxide safely reliability and accurately. And our research systems are already currently in us showing how showing evidence of antimicrobial effectiveness for hospital acquired pneumonia, COPD, CHF, TB, and RNA viruses. In addition to that, our home system has just passed through our first state first inhuman safety studies with with success and we're moving into to effectiveness studies at the end of this year, followed by our pivotal study and approval at the end of 2025. We also have formulated a liquid form of nitric oxide which can be injected. And this is really exciting because the same benefits of nitric oxide as a as a dilator can now be used as an injectable to treat vasospasm stitute both relieve and protect against phases out vaso spasms that result either due to mechanical insult due to catheterization or from a hemorrhagic stroke. This is a tremendous area that we expect to partner very soon. Based on the exciting animal results we just completed animal studies we just completed. We have a great team of folks, our engineering team are led by Christopher miles. All of our team members, including our engineering team are very familiar with moving class three medical device into the market. We understand the regulatory requirements and the quality initiatives necessary in order to do that. And we have a very experienced board starting with Bill Hyden, who was a former CEO of a mag as our chairman weren't a Cottrell's, former CEO of Solvay chemicals. Both had both Bill and Werner had successful large exits two major organizations were in a control sell Solvay chemicals to Avid for over $2 billion dollars. Matt Gaylord is the head of BD for abiy Ahmed also serves on our board. And Ron Robeson is the former head of medical affairs for ad V and Solvay has been a very, very helpful board member for us as we navigate through the FDA process. And Jeff McCormick is a well known innovation venture capitalists in Boston. So in summary, we have a category leading strategic investor validate our technology. That strategic investment came from the largest healthcare company in the world. And they spent nine months doing diligence before they invested a significant amount to get make sure that our no care hospital system got to the market, and was submitted by the end which we're targeting for the end of this year. They've checked out our technology, our team and our IP, we have two device platforms addressing the full continuum of care. We've designed to broaden access based on the affordability of our system, our system will be about a third of the cost of tank based nitric oxide. We have significant IP, the endocare system, as I mentioned, is being submitted at the end of this year for launch next year. And then we will have pivotal trial results for our our home product mid year next year. So it's very exciting time for the company. Thanks for your attention.

And let me just close by saying a couple of comments that really translate the impact that we plan on having you know, given this was a short time, I'm sure folks have questions. Please reach out. I'd love to hear from you and provide more details on our plans for doubling the existing $600 million market and creating a new category of care To finally enable patients to bring the benefits of nitric oxide home to treat their severely limited pulmonary hypertension, condition and much more. There's a there's a small amount of money left in our series B round in case you're interested. You can speak to me after the session. But more importantly, I want you to join us. So none of our so none of us as providers, patients or family members, in our time of need will hear I'm sorry, we can't provide you the best quality of care because we ran out of nitric oxide or we can't afford it or we can't take it home. You have my commitment, that third pole will be there to provide life saving nitric oxide wherever and whenever it's needed. Thank you all very much.